R&D IT Business Applications, Senior Manager

About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

As a R&D IT Business Applications, Senior Manager you will serve as the operational leader for the R&D IT function and create, support, and enhance the R&D technology landscape. This role will lead key initiatives, implement and validate new software applications, maintain GxP relevant systems and support R&D end users. As the primary point of contact for the R&D departments you will partner with key stakeholders from Clinical, Laboratory, Regulatory, Safety and other groups to support their business function and build strong relationships. The R&D IT Business Applications, Sr. Manager, reports to the Associate Director, R&D IT Business Applications for Merz Aesthetics and works at our Headquarters in Raleigh, NC.

What You Will Do

• Leadership:

• Articulate a clear and compelling strategy aligned with the global cultural tenets and strategic objectives of the company. Clearly define roles and responsibilities while holding members accountable for their performance. Develop talent and skills of individual team members. Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.

• Management:

• Functional Management of IT contractors including mentorship, performance management, and oversight. Project Management of IT projects including timelines and budget according to Merz SDLC. Vendor Management of 3rd party organizations including contracting, managed services, and enforcing service level agreements. Business Relationship Management of internal stakeholders ensuring technology meets business needs, challenges are solutioned, and trusted relationships are built and maintained. Portfolio Management including budget planning and controlling.

• IT Expertise:

• Act as IT System Owner and Administrator of GxP relevant applications. Create procedures, system documentation, and training materials to support the use of systems. Act as primary point of contact for R&D User support. Develop and implement solutions to support key business processes. Stay current on R&D relevant computer systems and industry trends.

• Computer Systems Validation:

• Validate GxP relevant software applications. Draft validation deliverables such as validation plans, requirements specifications, and test scripts. Manage change control process and release management cycle for applications. Stay current on global regulations including EU, ICH, and FDA guidelines.

• IT Compliance:

• Maintain systems in a validated state in accordance with Merz procedures. Perform routine authority checks on systems. Plan and schedule periodic system reviews, disaster recovery tests, and business continuity exercises. Assist with vendor audits and re-qualifications.

Minimum Requirements

• Bachelor of Applied Science (B.A.S.) in Computer Science/Information Systems or related discipline
• 5+ years of experience in a position of equal scope and responsibility
• experience supporting a life sciences and/or medical device R&D organization

Preferred Qualifications

• Recent experience with Computer Software Assurance principles and ALM tools.
• Experience and/or interest in AI Agents/Models in a GxP environment.

Technical & Functional Skills

• Experience in the pharmaceutical or medical device industry.
• Excellent written and oral communication skills as well as excellent interpersonal skills. Ability to present ideas in business-friendly and user-friendly language. Ability to develop and visually present ideas and concepts to both IT and Business stakeholders.
• Project management and presentation skills, superior analytical, evaluative, and problem-solving abilities as well as exceptional customer service.
• Extensive knowledge & experience with R&D IT systems used by Clinical (CTMS, eTMF), Laboratory (LIMS), Regulatory (RIMS), and Safety (PV Safety Database) and other R&D departments.
• Experience with systems implementation starting from request for proposal through business requirements analysis, design and configuration, implementation, and on-going support.
• Good knowledge of EU, ICH, FDA and validation guidelines.
• Exceptionally self-motivated and directed as well as ability to set and manage priorities.
• Strong interpersonal, teamwork, organizational and workload planning skills.
• Demonstrated analytical and conceptual thinking skills.
• Competency in training and support of users, service-oriented mindset.